Quality of healthcare services to reduce leprosy in Brazil: a trend analysis from 2001 to 2020

ABSTRACT Objective: To analyze the temporal trend of healthcare services quality indicators to reduce leprosy in Brazil, over a 20-year period. Methods: This is an epidemiological study with a temporal trend, whose data were extracted from the Notifiable Diseases Information System. Indicators were constructed from the Ministry of Health Technical-Operational Manual that presents the Guidelines for Surveillance, Care and Elimination of Leprosy as a Public Health Problem. For trend analysis of the selected indicators, the Prais-Winsten model was used and the Average Annual Growth Rate (AAGR) was also calculated. Results: In the 20-year time series investigated here, 732,959 cases of leprosy were reported in Brazil. The trend was stationary for: new leprosy cases cure rate (β=-0.000; p=0.196; AAGR=-0.2), new leprosy cases drop out rate (β=-0.001; p=0.147; AAGR=-0.4), new leprosy cases contact tracing rate (β=-0.001; p=0.112; AAGR=1.6), new cases of leprosy with degree physical disability assessment rate among new cases (β=-0.000; p=0.196; AAGR=-0.2) and cases cured in the year with the degree of physical disability assessed (β=0.002; p=0.265; AAGR=0.5); while the indicator of recurrence rate among cases reported in the year (β=0.019; p<0.001; AAGR=0.5) showed an increasing trend. Conclusion: Based on the evaluation of indicators to assess the quality of healthcare services to reduce leprosy, it was evident that Brazil has major challenges for its full implementation, with improvements being necessary in the quality of care service offered to the population.


INTRODUCTION
Leprosy remains a significant public health challenge due to its widespread prevalence and considerable disability impact, particularly affecting vulnerable and marginalized populations in middle and low-income countries 1 .Despite the implementation of policies and programs by the Ministry of Health aimed at its eradication 2 , leprosy continues to exhibit a high prevalence in Brazil 3 -which, globally, ranks second in number of reported cases -being classified, therefore, as a neglected disease with the potential for elimination 3 .
In 2020, a total of 127,396 new cases of leprosy were reported worldwide.Within the American continent, 19,195  (15.1%) cases were registered; of these, 17,979 were reported in Brazil, corresponding to 93.6% of the new cases reported in the Americas 4 .
In the 1980s, the World Health Organization (WHO) introduced polychemotherapy (poly-CT) as the treatment protocol for leprosy, a measure aimed at halting transmission and preventing deformities, which was also adopted in Brazil 5 .Subsequently, in 2002, the Ministry of Health established operational indicators to evaluate the effectiveness of interventions and services aimed at reducing and monitoring leprosy 6 .In 2016, with the publication of the Guidelines for Surveillance, Care, and Elimination of Leprosy as a Public Health Problem, operational indicators were designed to assess the quality of healthcare services in reducing leprosy 7 .
While literature offers studies on trend analysis of leprosy indicators, they predominantly concentrate on local and/or regional contexts, lacking publications with national coverage [8][9][10] .Furthermore, these studies often assess indicators over short time intervals 9,11 .Another notable gap is the limited research evaluating the quality of healthcare services aimed at reducing leprosy, as the majority of studies have focused on epidemiological indicators [11][12][13] .
Therefore, studies employing indicators to assess the quality of healthcare services aimed at reducing leprosy at a national level enable the monitoring of the impact of already implemented public policies.They also offer support to health managers in planning, decision-making, and program execution or improvements addressing the issue of leprosy in Brazil.Consequently, this study aimed to analyze the temporal trend of quality indicators of healthcare services to reduce leprosy in Brazil over a 20-year period.

METHODS
This epidemiological study examined temporal trends using indicators to assess the quality of healthcare services aimed at reducing leprosy in Brazil, encompassing a historical series from 2001 to 2020.
The data were sourced from the Notifiable Diseases Information System (Sistema de Informação de Agravos de No-tificação -SINAN) of the Ministry of Health, managed by the Information Technology Department of the Unified Health System (Departamento de Informática do Sistema Único de Saúde -DATASUS) 14 .Notifications with code A-30 were specifically chosen, falling under the "leprosy" category, recorded within the selected timeframe, and classified according to the criteria of the International Statistical Classification of Diseases and Related Health Problems (Tenth Revision), ICD-10 15 .
To assess the quality of healthcare services aimed at reducing leprosy, six indicators were employed.These indicators were derived from the Technical-Operational Manual, which outlines the Guidelines for Surveillance, Care, and Elimination of Leprosy as a Public Health Problem, issued by the Ministry of Health 7 (Chart 1).
The database was constructed using Microsoft Excel software, facilitating the calculation of proportions.Statistical analyses to assess the temporal trend and AAGR were conducted using the Stata statistical package (version 13.0).
To analyze the trend of indicators for assessing the quality of healthcare services aimed at reducing leprosy in Brazil, the Prais-Winsten linear regression test was employed 16 .The proportions corresponding to each evaluated indicator were considered as dependent variables, with the independent variable being the years within the historical series.
In the trend analysis, the β value of the proportions for each evaluated indicator was derived, representing the slope of the straight line.The rate of variation was utilized to classify the trend as follows: a positive rate of variation indicates an increasing time series, a negative rate of variation indicates a decreasing trend, and the trend is considered stationary when there is no significant difference between its value and zero.The level of significance was determined by comparing the p-value with the value provided by the standard normal curve, with a 95% Confidence Interval (CI).For all indicators, those with a model estimate yielding a p-value of <0.05 were deemed significant 17 .
The quantitative estimate of the trend is calculated by the following equation: AAGR=(-1+10 β )*100 Where: β corresponds to the angular coefficient formed in the linear regression.
To calculate the CI of the study measurements, the following formula was used: 95%CI=(-1+10 (β ± r*EP) )*100 Where: t = value at which Student's t distribution has 19 degrees of freedom at a two-tailed 95% CI; SE = standard error of the estimate of β, provided by the regression analysis.For all statistical tests performed, a significance level of 5% was adopted.Therefore, values of p≤0.05 were considered significant.
Following the criteria established by Resolution No. 466/2012 18

RESULTS
In the 20-year time series under investigation, a total of 732,959 cases of leprosy were reported in Brazil.Within this period, 545,610 cases of cure were documented.The overall proportion of leprosy cure among new cases diagnosed throughout the cohort years from 2001 to 2020 was 84.49%.The lowest proportion of cure was observed in 2019, while the highest was in 2007.Regarding the indicator for evaluating service quality, all years in the series -except for 2019, which was classified as precarious -were labeled as regular.This suggests that despite efforts to control and treat leprosy, effectiveness remains incomplete in Brazil (Table 1).
Regarding treatment abandonment, among new cases diagnosed in the cohort years, 34,999 cases were registered.The proportion of abandonment over the 20-year time series was 5.42%.The year with the highest number of abandonments was 2019, recording 1,971 cases, while the lowest number was in 2011 (1,425).In terms of the health care service quality parameter for the treatment abandonment indicator, all years received a good rating.During the investigated period, 2,131,711 contacts of new leprosy cases diagnosed in the cohort years were recorded, with 1,439,380 examined, representing a proportion of 67.5%.From 2001 to 2010, the quality of health service regarding the proportion of examined contacts of new leprosy cases diagnosed in the cohort years was classified as precarious.From 2011 to 2020, they were classified as regular, indicating the need to enhance health surveillance services (Table 1 Numerator: cases cured within the year with the degree of physical disability assessed at the time of cure, residing in a specific location.
Denominator: total cases cured within the year residing in the same location.Multiplication factor: 100.
Measure the quality of care in healthcare services.
Over the span of 20 years, 30,873 cases of recurrence were recorded, constituting a proportion of 4.1 among the cases reported during this period.The highest proportion of relapse occurred in 2018, while the lowest was observed in 2001.Regarding the proportion of new leprosy cases with a degree of physical disability assessed at diagnosis, an average of 88.9% was noted from 2001 to 2020.During this period, only the years 2006, 2009, 2010, and 2011 received a good classification for this indicator.The remaining years were classified as regular (Table 2).
Regarding the proportion of cases cured in the year with the degree of physical disability assessed among new cases of leprosy in the cohort period, the average proportion observed between 2001 and 2019 was 67.8%.This result was considered precarious (Table 2).

DISCUSSION
The findings of this study highlight the precarious quality of care for individuals diagnosed with leprosy, as well as shortcomings in surveillance capabilities and the effectiveness of actions for early case detection.These findings indicate a deviation from the standards recommended by the WHO 21 .
The trend analysis of the leprosy cure proportion indicator revealed unsatisfactory outcomes for individuals affected by the disease until the completion of treatment and achieving cure.A study conducted in Maranhão between 2002 and 2015, a period similar to that of the data presented here, also found a stationary trend for this indicator, that is, no progress in the number of cured cases 22 .Similarly, Machado 23 , in a historical series from 2003 to 2015, analyzing risk clusters for leprosy in Brazil, observed a stationary trend for the cure rate in most clusters, spe- cifically in 14 out of the 15 analyzed.This underscores the importance of involving health professionals in the treatment adherence process and the necessity for health education programs to enhance individuals' knowledge about leprosy.Improving the proportion of cured cases can facilitate the interruption of transmission and reduce instances of disability 23,24 .
The temporal trend of the indicator proportion of leprosy cases abandoning treatment was investigated, as it is inversely proportional to the effectiveness of the leprosy control program 25 , and it showed a stationary trend.A study conducted in Brazil between 2001 and 2015 reported an increase in the proportion of leprosy treatment abandonment 26 .These findings highlight the low effective- ness of the strategy to reduce treatment abandonment 27 , which could result in subtherapeutic dosing, leading to drug resistance and treatment failure 25,28 .
The indicator proportion of examined contacts of newly diagnosed leprosy cases exhibited a stationary trend, indicating that the capacity of services to conduct surveillance of new leprosy cases and promptly detect them is still considered precarious.Despite an improvement in classification during the second decade, transitioning from precarious to regular, the onset of the COVID-19 pandemic in 2020 likely caused a decline in the proportion, resulting in the indicator being classified as precarious once again.In a historical series presented by Souza et al. 29 , with data from the state of Bahia spanning from 2003 to 2014, an increasing trend was observed; however, even with this trend, the indicator was still classified as precarious.The approach to contacts is crucial for disease control, as it can provide counseling and systematic long-term monitoring of individuals and families at risk of illness, considering the disease's spread characteristics 29 .
Regarding the indicator proportion of new leprosy cases with degree of physical disability assessed at diagnosis, this indicator exhibited a stationary trend, maintaining a regular pattern throughout all years of the series.In the state of Paraíba, this indicator also demonstrated a stationary trend from 2001 to 2014; however, its classification remained precarious throughout the series, not exceeding 59% 30 .Conversely, in Minas Gerais, a state in the region with the lowest occurrence of the disease, although the indicator was classified as good, exceeding 90%, from 2008 to 2018, its trend was downward 31 .Therefore, it is crucial to note that the trend and classification of this indicator presented in this study, with data for Brazil, conceal the significant variability that exists between regions of the country.In this context, monitoring the implementation of active tracking programs for leprosy cases becomes essential, providing opportunities for disease control and reducing the proportion of cases with a degree of physical disability at the time of diagnosis 32,33 .
The indicator proportion of cases cured in the year with the degree of physical disability assessed among new cases of leprosy is crucial for evaluating the effectiveness of disease control strategies.Early diagnosis and treatment can mitigate the risk of physical disability and consequently improve the quality of life for patients 34 .A stationary trend was observed for this indicator, which, throughout all years of the investigated series, was classified as precarious.In Minas Gerais, a study conducted from 2008 to 2018 reported a regular classification for this indicator, but its decreasing trend led to a precarious level by the end of the series 31 .These findings highlight persistent challenges in evaluating and monitoring post-cure patients to ensure comprehensive care, including assistance for rehabilitation if needed.This aligns with the recommendations of the Brazilian Unified Health System (Sistema Único de Saúde -SUS) for continued care and support 11,25,33 .
In the present study, the indicator proportion of recurrence cases among cases reported in the year exhibited an increasing trend.A time series study conducted in Bahia from 2001 to 2014 similarly noted an increasing trend for this indicator, pointing to a rise in the number of municipalities reporting recurrence cases from 2008 to 2014 35 .Various predictive factors contribute to recurrence in patients diagnosed and cured, including treatment failure, reinfection linked to housing conditions and lifestyle habits, and the organization of health services.Additionally, professionals' failure to differentiate recurrences from reactions post-discharge can also influence recurrence rates 7,36 .Given this perspective and considering the upward trend of the indicator, there is a pressing need to develop and implement strategies aimed at reducing determinants contributing to recurrence cases 37,38 .It is crucial for services to distinguish relapse from situations involving reverse leprosy reaction, therapeutic insufficiency, and therapeutic failure.Cases unresponsive to proposed treatments for reactional states should be referred to reference units to confirm recurrence 39 .
In summary, Brazil still faces significant challenges on the path to eradicating leprosy, as it remains among the five countries that have not achieved the control target proposed by the WHO, persisting with high levels of endemicity 40 .The continual high number of new cases poses a substantial obstacle to leprosy elimination, contributing to the emergence of new cases through household contacts 41,42 .As demonstrated in this study, efforts to conduct contact exams, along with other indicators proposed by the leprosy control strategy, have fallen short.Moreover, the high incidence of the disease is closely intertwined with social determinants.Therefore, endemic countries like Brazil should integrate the eradication of poverty into their health policies.Actions within the health sector alone are deemed insufficient to address the diverse needs of the socially and economically marginalized populations 7,21,43,44 .
Although the results underscore the imperative to enhance the quality of healthcare services to reduce leprosy, it is essential to acknowledge some limitations of this study.The epidemiological design employed restricts the observation and analysis of the quality of leprosy care provided within the specific context of Brazilian municipalities 9 .
The limitations stemming from the utilization of secondary data from DATASUS must also be acknowledged, including gaps in data filling, the potential for underreporting, and inconsistencies in the flow of consolidated data within the system.However, leveraging this data enables access to a national registry encompassing a substantial final population, which is crucial for the epidemiological evaluation of neglected diseases.It can also facilitate assessment by managers and professionals, aiding decision-making and informing public health policy review and actions 17,45 .
Furthermore, the temporal analysis of the effectiveness indicators of preventive measures and the attainment of https://doi.org/10.1590/1980-549720240034their goals for eliminating leprosy in Brazil over a 20-year period enables the evaluation of the quality of healthcare services in implementing control actions.This process generates evidence that facilitates the adoption of strategies to address operational control challenges.
Furthermore, it is crucial to conduct further analyses with stratification according to regions so that policies can be tailored to the specific realities of each region of Brazil.Given the heterogeneous prevalence of the disease throughout the country and the vast territorial expanse, as well as the unequal distribution of resources, this adaptation is essential to ensure the effectiveness of health interventions.
Finally, given the current situation of leprosy in Brazil, it is imperative that the commitments outlined by the WHO for the elimination of the disease serve as guiding principles for the actions and policies implemented in the country.Addressing the challenges of overcoming delays in diagnosis, treatment, case monitoring, and active contact tracing requires financial investments to enable adequate training of professionals and improve the quality of healthcare services aimed at reducing leprosy in Brazil. https://doi.org/10.1590/1980-549720240034

Indicators used to evaluate the quality of health care services for reducing leprosy in Brazil 7 .
).Numerator: New leprosy cases residing in a specific location, diagnosed in the cohort years, and cured by December 31st of the evaluation year.Denominator: Total new leprosy cases residing in the same location and diagnosed in the cohort years.Multiplication factor: 100.
Numerator: new cases of leprosy with the degree of physical disability assessed at diagnosis, residing in a specific location and detected in the year of assessment.Denominator: new cases of leprosy, residing in the same location and diagnosed in the year of assessment.Multiplication factor: 100.

Table 2 . Quality of health care services for leprosy reduction in Brazil, from 2001 to 2020.
*No classifcation parameter specified.